MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD SYRINGE 5ML LL 22GA 1-1/4IN PTK 5

Catalog Number 308618

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Injury (2348)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the bd¿ syringe 5ml ll 22ga 1-1/4in ptk 5 has been found containing foreign matter before use.The following has been provided by the initial reporter: basically i observe that in the ¿union¿ of the needle and the plastic it has a kind of ¿white silicone¿ that stands out and hurts the patient.The defect was noticed during, before and after the use.The customer relate a injury due to the puncture.There was no need for medical or surgical intervention.

Manufacturer Narrative

H.6 investigation summary: samples and photos received for investigation.18 with opened package, 1 without package, and 1 piece belonging to savings pharmacies are received by the client, additionally 15 pieces of needle without syringe are received, which were sent to the quality control laboratory for visual evaluation.Samples were evaluated for epoxy stains, and surface of the cannula for any notches, burrs, fractures, scratches, or corrosion presence.During the tests performed, there are no characteristics similar to those reported by the client detected.During the documentary review, no attributable problem was found for the defect reported, in addition, the samples provided by the client presented compliant results in the tests performed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.

Event Description

It has been reported that the bd¿ syringe 5ml ll 22ga 1-1/4in ptk 5 has been found containing foreign matter before use.The following has been provided by the initial reporter: basically i observe that in the ¿union¿ of the needle and the plastic it has a kind of ¿white silicone¿ that stands out and hurts the patient.The defect was noticed during, before and after the use.The customer relate a injury due to the puncture.There was no need for medical or surgical intervention.

• Brand Name: BD SYRINGE 5ML LL 22GA 1-1/4IN PTK 5
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 9474978
• MDR Text Key: 198363255
• Report Number: 9614033-2019-00290
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 308618
• Device Lot Number: 9015861
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 11/29/2019
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other